BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173711 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11054
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    RECEIVED ADDITIONAL INFORMATION THAT THIS RV LEAD WAS SURGICALLY ABANDONED. THERE IS NO INTENDED RETURN OF THIS PRODUCT. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    -----

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT, WHO HAS THIS RIGHT VENTRICULAR (RV) LEAD, DEVELOPED A FEVER, LEUKOCYTOSIS, AND A (B)(6). ANTIBIOTICS WERE GIVEN TO THE PATIENT TO TREAT THE MRSA INFECTION. THIS WAS SUSPECTED TO BE DUE TO PATIENT CONDITION, AND NOT RELATED TO DEVICE MALFUNCTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1